Status:
RECRUITING
Eosinophil-guided Reduction of Inhaled Corticosteroids
Lead Sponsor:
Chronic Obstructive Pulmonary Disease Trial Network, Denmark
Conditions:
COPD
Inhaled Corticosteroid
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
Clinical trial on eosinophil-guided time-updated person-specific reduction of inhaled corticosteroid (ICS) therapy and prophylactic azithromycin therapy in patients with severe or very severe chronic ...
Detailed Description
Inhaled corticosteroid (ICS) treatment is recommended by Global Initiative for Obstructive Lung Disease (GOLD) for patients with frequent and/or servere exacerbations and blood eosinophils \> 0.3 x 10...
Eligibility Criteria
Inclusion
- COPD (verified by a specialist in respiratory medicine + spirometry)
- GOLD class E anytime within the last 2 years (corresponding to 2 ≥ AECOPD and/or ≥1 AECOPD leading to hospitalization during a 12 months period within the last 2 years) and/or FEV1\<30%.
- Treatment for last 4 weeks including LAMA, LABA and ICS
- Informed consent
Exclusion
- Known asthma.
- Male \< 40 years.
- Female \<40 years, if non-menopausal (had menstruation within the last 12 months) conditioned by a negative urine HCG test
- Severe mental illness which considerably complicates co-operation.
- Language problems that considerably complicate co-operation.
- Current treatment with systemic corticosteroids corresponding to \> 5 mg prednisolone per day.
- Systemic antibiotic treatment (if to participate in microbiota sub-study) or systemic corticosteroid treatment within 14 days (also prophylactic Azithromycin).
- Contra-indication to treat with Azithromycin (as listed by the producer).
- Non-bacterial exacerbation per investigator judgement in the last 3 months.
Key Trial Info
Start Date :
June 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
444 Patients enrolled
Trial Details
Trial ID
NCT04481555
Start Date
June 28 2021
End Date
December 31 2026
Last Update
March 13 2025
Active Locations (9)
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1
Aarhus University Hospital
Aarhus, Denmark
2
Hvidovre Hospital
Copenhagen, Denmark
3
Sydvestjysk Sygehus Esbjerg
Esbjerg, Denmark
4
Gentofte Hospital
Hellerup, Denmark